Kornimate/medical-research-clean huggingface dataset:
combination of inaticabtagene autoleucel with autologous hematopoietic stem cell transplantation for adolescents or adults with mrd-positive b-cell acute lymphoblastic leukemia in initial complete remission.

Conditions: B-cell Acute Lymphoblastic Leukemia

Summary: evaluate the safety and efficacy of inaticabtagene autoleucel combined with autologous hematopoietic stem cell transplantation in adolescents or adults with mrd-positive initial complete remission in b-cell acute lymphoblastic leukemia.

evaluate the safety and efficacy of inaticabtagene autoleucel combined with autologous hematopoietic stem cell transplantation in adolescents or adults with mrd-positive initial complete remission in b-cell acute lymphoblastic leukemia.

Eligibility criteria:
inclusion criteria: * ecog score of 0 to 1 * newly diagnosed ph-negative b-all within 6 months, achieving cr1 after standard induction chemotherapy, undergoing at least one consolidation therapy, and patients with bone marrow mrd ≥ 0.01% detected by routine flow cytometry. * or newly diagnosed ph-positive b-all within 6 months, achieving cr1 after guideline-recommended induction chemotherapy (or use of tki), undergoing at least one consolidation therapy, and patients with bcr-abl1 \&gt; 0% detected by routine q-pcr technology. * no significant organ dysfunction * willing and meet the conditions for autologous hematopoietic stem cell transplantation exclusion criteria: * burkitt lymphoma/leukemia, heterozygous or double-expressor leukemia, or chronic myeloid leukemia in blast phase. * before screening or pre-treatment, bone marrow or peripheral blood with blasts ≥ 5%; or extramedullary leukemia. * individuals who have received car-t cell therapy before screening or pre-treatment; or patients who have undergone hematopoietic stem cell transplantation. * patients with associated genetic syndromes related to bone marrow failure, such as fanconi anemia, kostmann syndrome, shwachman syndrome, or any other known bone marrow failure syndromes.

Keywords: inaticabtagene autoleucel autologous hematopoietic stem cell transplantation minimal residual disease
establishment of ideal iv sedative regimen for successful fiberoptic bronchoscopy in assessing the site, severity of sleep apnea syndrome

Conditions: Sleep Apnea Syndrome

Summary: venous thromboembolism(vte) is the third most common cardiovascular complication among hospitalized patients, and can even cause death. vte often occurs in intensive care patients and there had been many efforts to prevent such complication. the american college of chest physicians (accp) had published evidence-based clinical practice guideline for vte prophylaxis. this study focuses on how vte prophylaxis is being performed in both medical and surgical icus in a single university hospital, and sees the differences in such prophylactic patterns.


Eligibility criteria:
inclusion criteria: 1. 20-60 years old patients with asa class i-ii 2. scheduled for drug induced sleep endoscope after diagnosed with sleep apnea syndrome exclusion criteria: 1. patients having hearing difficulties, taking any cns related medication, history of any adverse drug reaction, glasgow coma scale \< 15 2. patients with severe cardiopulmonary dysfunction 3. patients refusal

Keywords: sleep apnea syndrome, fiberoptic bronchoscopy, iv sedation
anastomotic leakage and value of indocyanine green in decreasing leakage rates

Conditions: Colo-rectal Cancer; Crohn Disease; Resectable Colorectal Carcinoma

Summary: anastomotic leakage (al) is one of the major complications after gastrointestinal surgery. compromised tissue perfusion at the anastomosis site increases the risk of al. indocyanine green (icg) combined with fluorescent near infrared imaging has proven to be a feasible and reproducible application for real-time intraoperative quantification of the tissue perfusion and cohort studies showed reduced leakage rate. unfortunately, these studies were not randomized. therefore, we propose a nationwide randomized controlled trial to identify the value of icg for al in colorectal anastomosis.


Eligibility criteria:
inclusion criteria: 1. scheduled for laparoscopic or robotic-assisted colorectal resection with primary anastomosis; 2. patients aged over 18 years old; 3. has the ability to communicate well with the investigator in the dutch language and willing to comply with the study restrictions; 4. signed informed consent prior to any study-mandated procedure; exclusion criteria: 1. known allergy or history of adverse reaction to icg, iodine or iodine dyes; 2. severe liver or kidney insufficiency; 3. hyperthyroidism or a benign thyroid tumour; 4. pregnant or breastfeeding women; 5. scheduled for palliative surgery or terminal ill 6. scheduled for a diverting stoma 7. any condition that the investigator considers to be potentially jeopardizing the patients well-being or the study objectives (following a detailed medical history and physical examination; 8. subject taking phenobarbital, phenylbutazone, primidone, phenytoin, haloperidol, nitrofurantoin, probenecid; 9. emergency surgery
gastric emptying using two imaging methods for those who have undergone pose2 weight loss procedure

Conditions: Weight Loss

Summary: the purpose of this study is to compare a less invasive breath test against the current standard for assessing gastric (stomach) emptying. the current standard of care is a procedure called nuclear scintigraphy of a solid meal (nssm). this study will compare this method to a gastric emptying breath test (gebt).


Eligibility criteria:
inclusion criteria: * subjects must be 22-65 years of age at time of enrollment * subjects must already be consented to 17-007934 or 19-001254 * subject must be agreeable and compliant with study requirements, including up to three (baseline, 2 month, and 6 month) visits, as well as undergoing gebt and nssm testing. * if female, must be post-menopausal, surgically sterile, or agree to practice a form of birth control or abstinence during year of study and have negative serum hcg at screening/baseline * must be willing and able to travel, as needed, to the investigator's office to complete all routine follow-up visits exclusion criteria: * persons presently or soon to be incarcerated * females who are pregnant or suspect they may be pregnant * persons with nicotine and/or alcohol dependence * patients with cognitive impairment that limits their ability to make autonomous decisions * known allergies or sensitivities to study materials (eggs and spirulina) * assessed, by the physician or delegate, that enrollment would not be appropriate
virtual reality for appendectomy pain

Conditions: Appendix Rupture; Pain; Pain, Postoperative

Summary: to determine the impact of vr-biofeedback and vr-distraction on pain and medication utilization in children and adolescents undergoing surgery for ruptured appendix.


Eligibility criteria:
inclusion criteria: * age 8 - 18 years * able to read, understand, and speak english * patients in the immediate postoperative period following laparoscopic appendectomy for ruptured appendix exclusion criteria: * outside of age range (\ 18 years) * history of developmental delays, uncontrolled psychiatric conditions, or neurological conditions (especially epilepsy and/or significant motion sickness/nausea/vomiting) * history of vertigo, dizziness, and/or seizure disorders * conditions that would preclude the application of the vr headset, such as craniofacial deformities * history of chronic pain, frequent opioid use and/or active cancer therapy
study of safety and efficacy of h-1337 in subjects with primary open angle glaucoma or ocular hypertension

Conditions: Glaucoma Open-Angle Primary; Ocular Hypertension

Summary: the trial will evaluate the safety and efficacy of 3 dose regimens of h-1337 \[0.6% twice daily (b.i.d.), 1.0% b.i.d. and 1.0% once in the morning (q.a.m.), and timolol maleate (0.5%, b.i.d.) in both eyes for 28 days.


Eligibility criteria:
inclusion criteria: * diagnosis of bilateral primary open angle glaucoma or ocular hypertension exclusion criteria: * closed or very narrow angles (grades 0-1) or those the investigator judges as occludable and/or with evidence of peripheral anterior synechiae \>/= 180 degrees by gonioscopy within 6 months prior to screening visit in either eye note: other inclusion/exclusion criteria apply.
comparative study of two regiemns in management of sofosbuvir/daclatasvir failure

Conditions: HCV Coinfection

Summary: now many cases reported failure to hcv treatment with sofosbuvir/ daclatasvir. retreat those patients is challenging. so, we aimed to study the efficacy and safety of sofosbuvir /simeprevir/ daclatasvir/ribavirin versus sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis c patients who failed to prior sofosbuvir/ daclatasvir regimens in an open-labeled randomized trial.

hcv management with new daas is now promising. however, many cases reporting treatment failure either non-responder or relapse to hcv treatment with sofosbuvir/ daclatasvir. retreat those patients is challenging. so, we aimed to study the efficacy and safety of sofosbuvir /simeprevir/ daclatasvir/ribavirin versus sofosbuvir /ombitasvir/ paritaprevir/ritonavir/ribavirin in the management of hepatitis c patients who failed to prior sofosbuvir/ daclatasvir regimens in a multicenter open-labeled randomized trial.

Eligibility criteria:
inclusion criteria: * patients with proven chc genotype 4 * 18 years old or more, * prior hcv treatment failure to sofosbuvir /daclatasvir * compensated liver disease. exclusion criteria: * patients with combined hcv/hbv co-infection, hepatocellular carcinoma (hcc), decompensated liver cirrhosis (child-pugh score above 6), and non-genotype 4 were excluded.

Keywords: hcv daas non-responder
fecal transplantation in ulcerative colitis

Conditions: Ulcerative Colitis

Summary: adult individuals with ulcerative colitis in remission are given a single fecal microbiota transplantation (fmt) in colonoscopy. a half of the patients will receive autologous fmt as a placebo and a half will receive an fmt from a healthy donor.

80 adult patients with ulcerative colitis (uc) will be recruited. they are randomized to receive either an autologous fmt as a placebo or fmt from a healthy donor (frozen and thawed). the patients are followed up with fecal samples to detect microbial changes. the follow up lasts 1 year after the fmt and a follow up colonoscopy will be done 52 weeks after the fmt.

Eligibility criteria:
inclusion criteria: * • • diagnosis of cu based on clinical, endoscopic, and histological findings. * remission assessed by mayo score (0 to 1) and f-calpro (\<100 ug/g). * availability of consecutive fecal samples during one year after the diagnosis of cu. * availability of blood sample to study the ibd associated genetic background * compliance to attend ileocolonoscopy and fmt within 3-6 months after the diagnosis of cu and at 52 week * 18-75 years exclusion criteria: * unable to provide informed consent * need for any antibiotic therapy within 3 months * use of corticosteroids, immunosuppressive or biological medication at the baseline * use of any probiotics * pregnancy
immunology and safety of menactra® in children in saudi arabia

Conditions: Meningitis; Meningococcemia

Summary: this study will be conducted among children in saudi arabia who previously received two doses of a, c, y, w-135 polysaccharide vaccine before the age of 2 years, and in meningococcal vaccine-naïve children (control group). this study will evaluate the administration of menactra® in terms of the serum bactericidal antibody it induces in the two study groups. safety of menactra® vaccine will be described.


Eligibility criteria:
inclusion criteria : * healthy, as determined by medical history and physical examination. * aged between 5 to 8 years on the day of inclusion (from 5th birthday to 1 day before 9th birthday inclusive). * for the booster group , two doses of a quadrivalent (a, c, y, w-135) meningococcal polysaccharide vaccine received before age 2 years * for the control group , no previous history of any meningococcal vaccination * informed consent form signed by the parent(s) or other legal representative * able to provide a vaccination log or has available vaccination record in the health center. * able to attend all scheduled visits and to comply with all trial procedures exclusion criteria : * serious chronic disease (i.e., cardiac, renal, neurologic, metabolic, rheumatologic, psychiatric, etc.) * known or suspected impairment of immunologic function. * acute medical illness with or without fever within the last 72 hours or a oral temperature ≥ 37.5°c at the time of inclusion. * administration of immune globulin or other blood products within the last three months, injected or oral corticosteroids or other immunomodulatory therapy within six weeks of the trial vaccine. individuals on a tapering dose schedule of oral steroids lasting \< 7 days may be included in the trial provided that they have not received more than one course within the last two weeks prior to enrollment. * oral or injected antibiotic therapy within the 72 hours prior to vaccination. * received any vaccine in the 14-day period prior to trial vaccination, or scheduled to receive any vaccination during the 14-day period after trial vaccination. * previous history of documented invasive meningococcal disease. * for the control group, previous history of any meningococcal vaccination. * systemic hypersensitivity to any of the vaccines components or history of a life-threatening reaction to the trial vaccines or a vaccine containing the same substances. * participation in another clinical trial in the 4 weeks preceding the trial vaccination * planned participation in another clinical trial during the present trial period * any condition, which, in the opinion of the investigator, would pose a health risk to the subject, or interfere with the evaluation of the vaccine. * personal or family history of guillain barré syndrome.

Keywords: n. meningitidis meningitis meningococcemia
a repeat dose pharmacokinetic study of paroxetine cr tablet in healthy chinese subjects

Conditions: Depressive Disorder

Summary: the study was designed to assess the steady-state pharmacokinetic profile of paroxetine after 14 day repeated daily dosing of the controlled release tablet formulation (25 mg) in healthy chinese subjects.


Eligibility criteria:
inclusion criteria: * 19-45 years healthy chinese subjects * body weight \> 50 kg * bmi between 19-25 * serological negative for hiv, syphilis and hepatitis b and c * no abnormalities in ecg * female with negative pregnancy and male has no plan to have a child during and 3 months after the study. exclusion criteria: * history of chronic physical/mental disease, current disease and concomitant medication

Keywords: brl029060/paroxetine cr pharmacokinetics repeat dose
suture granuloma in body contouring surgery

Conditions: Skin Laxity of Abdomen, Thighs, Chest, Back, and Neck

Summary: the purpose of this study is to evaluate the effect of different suture material on the incidence of suture granuloma.

bariatric surgery has evolved as an effective treatment for morbid obesity, inducing rapid and predictable weight loss within a period of 12 to 18 months following surgery. consequently, body contouring after weight loss is emerging as the fastest growing field of plastic surgery. patients seek consultation with a plastic surgeon to correct skin laxity of the abdomen, thighs, chest, back, and neck. a major problem in body contourinig is the extrusion of absorbable suture material used for dermal closure. long incisions and high tension inherent to body contouring surgery mandate a secure dermal closure. while absorbable sutures are preferred, they can result in suture granuloma and extrusion.

Eligibility criteria:
inclusion criteria: men and women 18 years and older exclusion criteria: subjects with active infectious collagen disease,significant anatomic asymmetry that creates markedly different wound tension and/or geometry between left and right side subjects who cancel their surgery

Keywords: bariatric surgery body contouring skin laxity plastic surgery suture granuloma absorbable sutures
masticatory function in the differential diagnosis of stage iv periodontitis

Conditions: Periodontitis

Summary: this is a pilot diagnostic accuracy study to assess the ability to discriminate in a screening context stage iv periodontitis from other stages of periodontitis. the index test is the assessment of masticatory dysfunction performed with a questionnaire and a chewing gum test. the reference standard is a full periodontal and functional assessment performed by a trained and calibrated specialist.

this is a pilot diagnostic accuracy study. data are derived from a cross-sectional study based on a convenience, quota sample of patients referred for dental care to the reception clinic of the prince philip dental hospital or at the institute of advanced dentistry, the university of hong kong between october 2020 and may 2021. the study will be conducted in accordance with the current revision of the declaration of helsinki. informed consent will be obtained from all participants prior to enrollment in the study. this study will follow the standards for reporting diagnostic accuracy (stard) guidelines. to limit bias, separate calibrated examiners performed the index test (chewing gum test) and the periodontal examination used for periodontitis stage and grade diagnosis (reference standard). to evaluate the diagnostic accuracy of masticatory function assessment for stage iv periodontitis, logistic regression analyses will be conducted in univariate analyses and the area under the receiver operating characteristic curve (auroc), diagnostic odds ratios (dors), sensitivity, specificity, positive predictive values and negative predictive values will be calculated. multivariate logistic regression models will be applied to develop a screening algorithm for stage iv periodontitis diagnosis including the masticatory function assessment and other candidate predictors. a backward stepwise selection method will be used (p = 0.05 for inclusion in model; p = 0.05 for removal from model). the standard nomenclature for interpreting low, moderate and high levels of accuracy will be based on sensitivity and specificity as well as the auroc values: low level = sensitivity or specificity \ 0.90

Eligibility criteria:
inclusion criteria: * periodontitis subjects reporting for care at reception clinic of dental hospital exclusion criteria: * presence of temporomandibular disorders, * subjects undergoing orthodontic treatment * less than 12 teeth; * subjects having received periodontal treatment in the previous 12 months; * subjects having received antibiotic medication in the previous 3 months

Keywords: periodontitis screening diagnostic accuracy
to assess the efficacy and safety of the probiotic e. coli strain m17 on patients with gerd

Conditions: GERD

Summary: the study is an open label, prospective, non comparative, pilot, clinical trial design. patients with inadequate relief in gi symptoms associated with gerd despite ppi treatment will be screened and those who meet the inclusion and exclusion criteria will perform a glucose breath test for bacterial overgrowth . each patient will then complete a questionnaire to record their gerd related symptoms. each patient will then receive a daily intake of 30 ml two times daily, 30 minutes before meals for a period of 4 weeks. during the course of the trial, they will have 4 visits with the study physician to assess treatment compliance and occurrence of adverse events, and will complete periodic daily diaries to record compliance.


Eligibility criteria:
inclusion criteria: 1. age between ≥18 and ≤80, males and females. 2. patient administered ppi therapy for gerd. 3. patient suffers from any gi symptoms including gerd symptoms despite ppi therapy for at least 60 days 4. patient with positive or negative glucose breath test for bacterial overgrowth unless they are not able to do this secondary to diabetes. diabetics will have a lactulose breath test 5. able to give informed consent 6. candidate will be available for the next 4 weeks exclusion criteria: 1. pregnant, breast-feeding, or not using approved methods of contraception (if of childbearing potential) 2. unstable medical disorder 3. patient has had e. coli strain m17 administered in the past month 4. history of major psychiatric disorder or substance abuse within the previous 2 years, including psychiatric illnesses requiring medication that may cause doubt in the validity of the signed informed consent form 5. existing illness or medical condition that will prevent the patient from participating in the study (such as severe heart disease, insulin dependent diabetes, hyperactive thyroid gland, hiv positive, etc.) 6. participation in another clinical study during the past four weeks. 7. any use of a probiotic supplement within 30 days of the screening period (with the exception of standard food yogurt products) 8. any use of antibiotics within 30 days of the screening/enrollment period (however, candidate may wait to initiate screening exam until 30 days have lapsed since antibiotic course was completed) -
the effect of thoracic mulligan mobilization on sub-acromial impingement syndrome

Conditions: Shoulder Impingement Syndrome

Summary: this study was conducted to investigate the effect of mulligan thoracic sustained natural apophyseal glide on patients diagnosed as sub acromial impingement syndrome and its effect on shoulder range of motion, pain, function and disability of affected shoulder joint and size of sub acromial space, half of the patients will treated with traditional treatment and mulligan thoracic snags technique, while the other half will treated with traditional treatment only.

forty patients with sub-acromial impingement syndrome will participate in this study. intervention for the both group consisted of 12 session (3 times per week ) for one month. subjects will be divided randomly and allocated into two groups , study group will received supervised exercise and mulligan thoracic snags technique and the control group will received supervised exercise (stretching and strengthening exercises). both group will assessed by x ray to measure sub-acromial space , visual analogue scale for pain , the shoulder pain and disability index for shoulder function and goniometer for shoulder flexion, abduction ,external and internal rotation range of motion before and after treatment.

Eligibility criteria:
inclusion criteria: 1. patients referred as sub-acromial impingement syndrome (stage 2) according to neer's classification. 2. have +ve neer's sign, +ve hawkins and kennedy test and +ve empty and full can tests. 3. selected from both genders. 4. aged from 25 to 40 years old. 5. have restricted thoracic extension motion ( +ve occiput to wall test). exclusion criteria: 1. history of shoulder adhesive capsulitis 2. rotator cuff tendon tear/rupture (stage 3). 3. shoulder dislocation, subluxation and fractures. 4. history of cervical, shoulder, upper back surgery. 5. any spinal deformities such as scoliosis, kyphosis and rounded shoulder. 6. diabetes mellitus. 7. radiculopathy. 8. history of breast cancer. 9. previous stroke or shoulder hand syndrome. 10. ligamentous laxity.

Keywords: subacromial impingement syndrome mulligan thoracic sustained natural apophyseal glides acromiohumeral distance or subacromial space